About this trial
Patients participating in this research study (also known as a clinical trial) will either recieve a drug called called divarasib in combination with pembrolizumab or they will receive pembrolizumab in combination with chemotherapy. To be eligible for the study, patients need to have a special kind of genetic change called the KRAS G12C mutation (in full, this mutation is called a Kirsten rat sarcoma viral oncogene homolog [KRAS] glycine 12 to cysteine [G12C] mutation).
Divarasib has been designed to block the KRAS G12C mutation which can promote the growth of cancer cells.Divarasib is an experimental drug, which means health authorities have not approved it in combination with pembrolizumab for the treatment of previously untreated
locally advanced or metastatic lung cancer with a KRAS G12C mutation.
Pembrolizumab is a monoclonal antibody. A monoclonal antibody is an antibody (a type of protein) that has been designed to recognise and attach to a specific structure (called an antigen) that is found on certain cells in the body. Pembrolizumab has been designed to attach to and block an antigen called ‘programmed cell death-1’ (PD-1), which switches off the activity of certain cells of the immune system (the body’s natural defences) called T cells. By blocking PD-1, pembrolizumab prevents PD-1 from switching off these immune cells. This increases the ability of the immune system to kill tumour cells. It has been approved for the treatment of certain types of Lung Cancers alredy.
If patients are taking part in the control arm, you will receive chemotherapy consisting of two different medications in combination with pembrolizumab: pemetrexed and either cisplatin or carboplatin. This combination of drugs is commonly used in the treatment of
lung cancer and is approved by health authorities worldwide as a treatment, either alone or with immunotherapy, for several types of cancers.
Patients who are eligible to participate on this study will be assigned by chance (one chance in two) to one of two treatment groups via a process called randomization. The experimental Group (Divarasib & Pembro) or Control Group Pembro and Chemotherapy).
During this study, patients will have visits approximately weekly or every other week for the first 4 cycles (a cycle is a 21 day period) and then approximately every 3 weeks thereafter while you are receiving treatment.Patients will continue to take study treatment on a regular basis unless their lung cancer worsens or you have medically unacceptable side effects. After final dose, thestudy doctor will follow-up with patients about every 3 months for as long as you agree to it.
The total time in the study will depend on how patient’s lung cancer responds to treatment.
This could range from 1 day to more than 5 years.
Patient Profile
The patients will have non-small cell lung cancer that is locally advanced or metastatic (has grown or spread) and have not received prior chemotherapy or immunotherapy for this type of disease. Previously Untreated, KRAS G12C-Positive, Advanced or Metastatic Non Squamous Non-Small Cell Lung Cancer
Where’s this trial being run?
Beaumont Hospital, St James’s Hospital, Tallaght University Hospital, and Mater Misericordiae University Hospital
Can I join this study / trial?
The first step we recommend is to talk to your doctor or the cancer trials team at your hospital. You can find contact details for cancer trials research units in Ireland here.
It’s also a good idea to print this page and bring it with you to your appointment. It can help guide the conversation and remind you of what to ask. You may also want to talk to your family or friends about your options, as they can offer support as you make decisions.
For more detailed information
Click HereQuestions?
Here’s a list of questions you may have for your doctor or local cancer research team.
QuestionsSummary Data
| Name: | KRASCENDO-2 |
|---|---|
| Number: | 25-23 |
| Full Title: | A Study Evaluating the Efficacy and Safety of Divarasib and Pembrolizumab Versus Pembrolizumab and Pemetrexed and Carboplatin or Cisplatin in Participants With Previously Untreated, KRAS G12C-Mutated, Advanced or Metastatic Non-Squamous Non-Small Cell Lung Cancer (Krascendo 2) |
| Principal Investigator: | Prof Patrick Forde |
|---|---|
| Type: | Industry Sponsored |
| Sponsor: | Roche |
| Recruitment Started: |
Global: Ireland: |
| Global Recruitment Target: | 600 |
|---|---|
| Ireland Recruitment Target: | 8-12 |